Open Label , Randomized, Three Arm Parallel Group Single Dose Comparative Pharmacokinetic , Safety and Immunogenicity Study in Healthy Subjects

NCT06929039 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: KSHB002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Test Product KSHB002 shows equivalence in terms of PK , safety and immunogenicity as compared to reference product ORENCIA used to treat Rheumatoid arthritis . Participants will: Take drug Test or a reference subcutaneously as a single dose and these participants will be healthy volunteers Primary Endpoint: The following pharmacokinetic parameters will be determined as: Cmax and AUCi, of KSHB002 (Abatacept), US-licensed ORENCIA and EU-authorized ORENCIA. Secondary Endpoint : Safety will be evaluated from occurrence of adverse events post dose. The number, severity and relation to treatment will be collected by the reporting of the adverse events (AE) and monitoring of clinically relevant changes e.g., vital signs, physical examination and lab values in blood and urine.

• Immunogenicity will be evaluated from the number/percentage of subjects positive for ADA (Anti-Drug Antibody) and Neutralizing Anti-drug antibody
• Secondary pharmacokinetic endpoints will be evaluated as AUCt, Tmax, Kel and tHalf.

Conditions

Rheumatoid Arthritis (RA

Keywords

abatacept; kashiv biosciences

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic parameter

  Cmax

  from baseline till day 70

• Pharmacokinetic parameter

  AUCi

  from baseline to day 70

Secondary Outcomes (4)

• Pharmacokinetic parameter

  from baseline to day 70

• pharmacokinetic parameter

  from baseline to day 70

• Pharmacokinetic parameter

  Baseline to day 70

• Pharmacodynamic

  basleline to day 70

Study Arms (3)

Test Product

EXPERIMENTAL

Test Product- KSHB002 Abatacept 125mg/ml Pre-filled syringe

Drug: Abatacept

Reference Product 1

ACTIVE COMPARATOR

US-Liceneced Orencia 125mg/ml Pre-filled syringe

Drug: Abatacept

Reference product 2

ACTIVE COMPARATOR

EU-Approved Orencia 125mg/ml pre-filled injection

Drug: Abatacept

Interventions

Abatacept DRUG

Test Product (A) (Kashiv's Abatacept): KSHB002 (Abatacept) Injection, 125 mg/mL - Manufactured by: Kashiv Bioscience's LLC, USA.

Test Product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and/or non-pregnant, non-lactating female. A. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test at screening. They must be using an acceptable form of contraception.
• B. For female of childbearing potential, acceptable forms of contraception include the following:
• i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.
• C. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
• i. Postmenopausal with spontaneous amenorrhea for at least one year, or Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level \> 40 mIU/mL, or iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iv. Total hysterectomy and an absence of bleeding for at least 3 months. 3) BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.95 rounds up to 19.0).
• \) Body weight: 50.0 kg to 100.0 kg both inclusive. 5) Able to communicate effectively with study personnel. 6) Willing to provide written informed consent to participate in the study. 7) Judged by the investigator and/or designee to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any clinical testing (laboratory tests, ECG, etc.) can be repeated at the discretion of the investigator and/or designee and judged to be not clinically significant for study participation. Any abnormalities or deviations outside the normal range for vital signs can be repeated by clinical staff and judged to be not clinically significant for study participation

You may not qualify if:

• History of allergic responses to Abatacept or other related drugs, or any of its formulation ingredients.
• \) Any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
• \) History or presence of chronic obstructive pulmonary disease (COPD). 4) Use of any hormone replacement therapy within 3 months prior to the study medication administration.
• \) Use of any depot injection or implant of any drug within 3 months prior to the study medication administration.
• \) Use of CYP enzyme inhibitors or inducers within 30 days prior to the study medication administration (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
• \) History or evidence of drug dependence. 8) Reports smoking or using tobacco products or is currently using nicotine products (cigarettes, patches, gums, etc.) 14 days prior to screening.
• \) Reports history of drug or alcohol addiction or abuse within the past 1 year.
• \) History of difficulty with donating blood or difficulty in accessibility of veins.
• \) A positive hepatitis screen (hepatitis B surface antigen, hepatitis C antibody).
• \) A positive test result for HIV antibody. 13) A positive QuantiFERON®-TB Gold Plus (Tuberculosis) test. 14) Volunteers who have received a known investigational drug within seven elimination half-lives of the administered drug prior to the study medication administration.
• \) Reports a blood donation totaling between 101 mL to 499 mL within 30 days prior to study drug administration or a blood donation of more than 499 mL within 56 days prior study drug administration for male volunteers and 84 days prior to study drug administration for female volunteers. All volunteers will be advised not to donate blood for 30 days after completing the study.
• \) Intolerance to venipuncture 17) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study.
• \) Institutionalized volunteers. 19) Use of any prescribed medications within 14 days prior to the study medication administration.
• \) Use of any OTC products, vitamin and herbal products, etc., within 14 days prior to the study medication administration.
• \) Use of grapefruit and grapefruit containing products within 7 days prior to the study medication administration.

Sponsors & Collaborators

• Kashiv BioSciences, LLC: lead

Study Sites (1)

Not Disclosed

Missisauga, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Dr Uday Harle, PhD Med

  Kashiv Biosciences

  STUDY CHAIR

• Dr Pallav Bharpoda, MBBS

  Kashiv Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: April 15, 2025
• Study Start: July 4, 2024
• Primary Completion: October 16, 2024
• Study Completion: February 25, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-01

Locations

CA (1)